OrderlyMeds' Response to Eli Lilly's Cease-and-Desist Letter

 On April 01, 2025, OrderlyMeds received a Cease-and-Desist letter from Eli Lilly regarding the compounding of Tirzepatide. This is our open response.

Prescribers and pharmacists have been taking care of their patients with customized, compounded medications since before Eli Lilly existed. Compounding medications for individual patients allows healthcare providers to customize treatments that reflect each person's unique medical needs.  Patients with allergies, vulnerability to side effects, dosage sensitivities, and other personal needs benefit from treatment tailored to their individual needs.  In contrast, manufactured products are inherently standardized and not custom.  Tirzepatide is no exception.

At OrderlyMeds, we believe that patients deserve a say in their own healthcare and wellness goals.  OrderlyMeds believes that each person is unique and deserves an individualized medical regimen.  Compliantly compounded medications is a critical tool to meet those goals.

Eli Lilly's Cease-and-Desist letter only reinforces and reinvigorates OrderlyMeds' mission to provide patients with tailored healthcare solutions, access, and choice. So, rest assured that OrderlyMeds will defend itself and our patients against these attacks that aimed solely at driving shareholder value for Big Pharma, not the individualized needs of you, the patient.

So, what does this mean for our patients? Nothing. OrderlyMeds will continue providing its patients with the dedicated and individualized care you have come to know and love. We will fight for you, the patient, in order to ensure the continuation of your personalized healthcare.

While for many of you, your path on a GLP-1 medication may be your first exposure to compounding pharmacies, the practice of compounding medications has been around since the beginning of pharmacies in the United States.  The practice of compounding is subject to strict rules and requirements.

Just as we are committed to patient access to care, we are equally committed to patient safety. You are and always will be our priority.

We stand with our colleagues in the compounding industry and are committed to continued access to patient-specific medications. Please stay tuned for updates and know that OrderlyMeds will continue to fight for you!

Healthy regards,
Chris Spears  |  Founder & CEO

https://finance.yahoo.com/news/orderlymeds-response-eli-lillys-cease-113000352.html

Verve Fast Track Designation for Medicine Targeting Hyperlipidemia

Verve Therapeutics has received FDA Fast Track designation for VERVE-102, an investigational base editing medicine targeting PCSK9 for treating hyperlipidemia patients with high cardiovascular risk. VERVE-102 is designed as a single-course treatment to permanently deactivate the PCSK9 gene in the liver and reduce LDL-C levels.

The treatment is currently in Phase 1b Heart-2 clinical trial, evaluating safety and tolerability in patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). The company plans to announce initial safety and efficacy data from the first three dose cohorts (0.3, 0.45, and 0.6 mg/kg) in Q2 2025.

The Fast Track status may enable more frequent FDA communications and potential Priority Review. Verve plans to report final dose escalation data, deliver the opt-in package to Eli Lilly, and begin Phase 2 trials in H2 2025.

https://www.stocktitan.net/news/VERV/verve-therapeutics-receives-u-s-fda-fast-track-designation-for-verve-96qbo36znugw.html

Amgen pads Imdelltra's case in tough-to-treat lung cancer subtype with phase 3 survival win

 Nearly a year after winning an accelerated approval for its DLL3-targeting small cell lung cancer (SCLC) therapy Imdelltra, Amgen is further proving the drug's worth with overall survival data from an interim analysis of a phase 3 study. 

Topline results proved that Imdelltra use resulted in “statistically significant and clinically meaningful” improvement in overall survival compared with local standard-of-care chemotherapy across patients with SCLC whose disease progressed after one line of platinum-based chemotherapy, Amgen reported.

The findings demonstrate “overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as standard of care," Amgen’s Executive Vice President of R&D Jay Bradner, M.D., noted in a statement. “We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide."

The data could potentially be used to support a full approval for Imdelltra. The FDA blessed the drug with an accelerated approval in extensive-stage SCLC ahead of schedule last May based on a phase 2 trial in which Imdelltra reduced tumors in 40% of SCLC patients who had failed on two prior lines of treatment and proved a median duration of response of 9.7 months. The nod made the drug the first FDA-approved bispecific T-cell engager cleared to treat the disease. 

Those phase 2 results represented a “watershed moment” for Amgen’s oncology team, chief medical officer Paul Burton, M.D., told Fierce Biotech in 2023.

“This represents about a tripling of the duration of survival,” Burton said at the time.

SCLC is a tough-to-treat and aggressive lung cancer subtype that has a 5% to 10% five-year relative survival rate across all stages combined. While patients typically have high initial response rates to first-line platinum-based chemotherapy, most quickly relapse within a few months, according to Amgen.

While the phase 2 data was enough to snag an accelerated approval, there was a bit of a safety concern with Amgen’s initial drug approval application. As it turns out, nearly 400 adverse events were not reported in the original application, an FDA review document revealed a few months after the approval. Amgen later conducted a sweeping review of its trial sites and was able to add the missing safety events to the drug’s application midway through the FDA’s review process. 

The “large number” of underreported events was a “major concern” to FDA reviewers, but the agency ultimately decided that Amgen’s source data verification for the trial sites were “acceptable to support” the application.

In the more recent phase 3 study, the safety profile for Imdelltra was “consistent” with its known profile. The drug comes with a black-box warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. In the phase 2 trial, 55% of patients who used the therapy experienced CRS.

Imdelltra picked up $115 million in 2024 sales and has been pegged as a potential blockbuster with William Blair analysts previously projecting $842 million in 2028 sales. The company is also weighing the drug in several studies across earlier lines of SCLC treatment both on its own and in combination regimens.

https://www.fiercepharma.com/pharma/amgen-pads-imdelltras-case-tough-treat-lung-cancer-subtype-phase-3-survival-win

Jefferies raises Nektar stock to buy, doubles price target

 On Friday, Jefferies analyst Roger Song upgraded Nektar Therapeutics (NASDAQ:NKTR) stock from Hold to Buy, doubling the price target from $1.00 to $2.00. The decision comes as Nektar prepares to announce the top-line results of their Phase 2b study for Rezpeg, a novel treatment for Atopic Dermatitis (AD), in the second quarter of 2025. Currently trading at $0.50, the stock has seen a significant decline of over 63% in the past six months. 

Song reviewed the Phase 1b data for Rezpeg, an IL-2 Treg stimulator, and noted its promising efficacy and safety profile, which shows a novel mechanism of action (MOA) when compared to existing and pipeline competitors in the AD market. Based on these findings, Jefferies anticipates a favorable outcome from the upcoming data readout. While the company maintains a strong liquidity position with a current ratio of 4.26, it's currently experiencing rapid cash burn - one of 14 key insights available to Pro subscribers.

The upgrade reflects Jefferies' analysis of the potential market impact of Rezpeg and its unique MOA. With the current significant negative enterprise value (EV) of Nektar, Jefferies sees a skewed probability of reward versus risk ahead of the study results. This assessment has led to a more optimistic outlook on Nektar's shares, prompting the firm to advise investors of the stock's buy status. The company's market capitalization stands at $93 million, with analyst price targets ranging from $1.00 to $7.00. 

The forthcoming Phase 2b study results are highly anticipated by both the company and investors, as they will provide critical insights into Rezpeg's potential as a treatment for AD. The increase in the price target to $2.00 is indicative of Jefferies' confidence in the success of Rezpeg and its impact on Nektar's financial performance.

Investors will be closely watching the market's response to the Phase 2b study results, which are expected to play a significant role in Nektar's future growth and positioning in the AD treatment landscape. The upgraded rating and revised price target by Jefferies signal a positive shift in market expectations for Nektar Therapeutics.

https://www.investing.com/news/analyst-ratings/jefferies-raises-nektar-stock-to-buy-doubles-price-target-93CH-3980917

Wells Fargo starts Sarepta at Buy, price target at $115

 Wells Fargo (NYSE:WFC) initiated coverage on Sarepta Therapeutics (NASDAQ:SRPT), currently trading at $50.31, assigning an Overweight rating to the biopharmaceutical company with a price target set at $115. The firm's analyst, Yanan Zhu, expressed confidence in the company's Duchenne muscular dystrophy (DMD) treatments, including the gene therapy ELEVIDYS, despite a recent adverse event report. According to InvestingPro data, the stock is trading near its 52-week low of $48.01, with technical indicators suggesting oversold conditions.

Zhu highlighted that ELEVIDYS is still considered the best treatment option for most young DMD patients, and the commercial opportunity for Sarepta remains substantial. Wells Fargo does not anticipate significant alterations to the product's labeling and views the recent market downturn as a chance to invest in the company at a value. The company's strong financial position is evident in its current ratio of 4.2, indicating ample liquidity to fund its operations. InvestingPro subscribers can access 12 additional key financial metrics and expert insights about Sarepta's market position.

The price target of $115 is based on a discounted cash flow (DCF) analysis, with a large portion of the valuation driven by the commercial success of Sarepta's approved DMD products. These include the gene therapy ELEVIDYS and three exon-skipping products, with gene therapy being the primary value driver, contributing three times more than the exon-skippers to the company's worth. The company has demonstrated strong revenue growth of 53% over the last twelve months, supporting the bullish valuation thesis.

Wells Fargo's projection includes global sales for ELEVIDYS reaching $1.6 billion in 2025 and peak sales estimated at $3.5 billion by 2028. These figures take into account both ambulatory and non-ambulatory patient populations, suggesting a robust market demand for the therapy in the coming years.

https://in.investing.com/news/analyst-ratings/wells-fargo-sets-sarepta-stock-price-target-at-115-93CH-4771000

'China considers allowing Western firms to make markets in its ETFs'

 China is contemplating allowing Western companies, such as Citadel Securities and Jane Street, to operate as market makers in its rapidly expanding exchange-traded fund (ETF) sector, according to a Reuters report on Friday.

In the past two years, Chinese authorities have granted more licenses and promoted the growth of domestic market makers. However, international market makers have more experience in supplying liquidity to ETFs, which could enhance trading efficiency and reduce costs, the report added.

The report also warned that the intensifying trade conflict with the U.S., which has resulted in China facing tariffs of 145% this year, could postpone Beijing's official approval for U.S. firms.

https://www.investing.com/news/stock-market-news/china-considers-allowing-western-firms-to-make-markets-in-its-etf-93CH-3981644

Bristol Myers combo follows Roche, AstraZeneca immunotherapy rivals into first-line liver cancer

Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.

The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.

The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.

The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.

All three combos got their FDA approvals based on phase 3 evidence showing that they could help patients live longer versus traditional targeted therapy. The BMS regimen is unique in that its comparator included Merck & Co. and Eisai’s Lenvima, which is considered a more powerful tyrosine kinase inhibitor in the first-line liver cancer armamentarium. 

According to results from the CheckMate-9DW trial, Opdivo and Yervoy significantly reduced the risk of death by 21% compared with either Lenvima or Bayer’s Nexavar. The BMS cocktail extended patients’ median survival time by 3.1 months to 23.7 months.

Opdivo and Yervoy mounted that statistically significant showing despite the control arm’s 20.6 months of median overall survival notably outperforming historical data, including in phase 3 trials that got Roche and AZ their first-line liver cancer nods from the FDA in 2020 and 2022, respectively.

An updated analysis from Imbrave-150 showed that Tecentriq and Avastin reduced the risk of death by 34% versus Nexavar alone, with a median overall survival of 19.2 months and 15.6 months, respectively.

In the phase 3 Himalaya trial, AZ’s Imfinzi and Imjudo slashed the risk of death by 22% compared with Nexavar. The median overall survival was 16.6 months for the PD-L1/CTLA-4 combo or 13.8 months for control.

The CheckMate-9DW results and increasing evidence positioning Lenvima as a more efficacious first-line liver cancer drug than Nexavar raised the question of whether Opdivo-Yervoy—or any one of the three immunotherapy regimens—can beat Lenvima head to head.

CheckMate-9DW isn’t designed to answer that question. Merck tried by pairing Lenvima with Keytruda, but the phase 3 Leap-002 trial failed to show a statistically significant survival benefit for that combo against Lenvima monotherapy.

BMS’ Bartie also pointed to Opdivo and Yervoy’s tumor response data. The combo triggered a 36% objective response rate in the trial, compared with 13% of patients responding to either Lenvima or Nexavar. Median duration of response was more than doubled with the combo at 30.4 months versus 12.9 months for the control, although this comparison is not included in the statistical plan of the trial.

What’s more, at three years, about 38% of patients on the Opdivo-Yervoy pairing remained alive in CheckMate-9DW, versus 24% of those in the control arm.

“We’ve consistently heard in market research from our customers is that they will use immunotherapy combinations when the data demonstrates that it is significantly better than [Lenvima] or [Nexavar], as an example,” Bartie said. “I think when you look at the strength of this data, particularly the overall survival rates, that is what will drive physician choice.”

Besides the three Big Pharma players, Jiangsu Hengrui Pharma and its partner Elevar Therapeutics are also trying to bring their China-approved checkpoint inhibitor-based combination of camrelizumab and rivoceranib to the first-line treatment setting for liver cancer in the U.S. The FDA recently rejected the partners’ applications for the second time, again because of manufacturing issues. 

https://www.fiercepharma.com/pharma/bristol-myers-combo-follows-roche-astrazeneca-immunotherapy-rivals-first-line-liver-cancer