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Tuesday, October 11, 2022

PureTech and Nektar Call Off Rumored Merger

 Last week, rumors spread that PureTech Health was preparing to merge with Nektar Therapeutics. Now the deal, never officially announced, has been called off.

When the rumors first broke, PureTech released a statement on Oct. 6 confirming the two companies were in negotiations, but that they were “non-binding” and “there can be no certainty that any firm offer will be made, nor as to the terms of any such offer.”

Tuesday, in a K-6 filing and release, PureTech announced the two companies had agreed to terminate discussions.

Further, PureTech indicated the discussions had been very early, but under U.K. regulations, were required to be announced.

According to a statement from PureTech: “These discussions were early in nature and the required announcement created the impression that discussions were more advanced than they were. Given the early stage of the discussions and the potential for an extended period of uncertainty, these discussions were terminated.”

PureTech shares took a hit, plunging 21%, while Nektar’s dropped 4.3%.

PureTech leverages what it calls Founded Entities that focus on specific drug development programs. Its pipeline includes fibrotic and immunological diseases, difficult-to-treat cancers, lymphatic and gastrointestinal diseases and neurological and neuropsychological disorders.

Nektar focuses on therapies that selectively modulate the immune system to treat cancer, autoimmune disorders and chronic inflammatory diseases.

Allison Mead Talbot, PureTech’s head of communications, told BioSpace PureTech was not looking to be acquired.

“We regularly evaluate multiple ways to enhance value for our shareholders, including opportunities to further grow our pipeline and cash position,” she said.

Talbot said the company is “a financially robust and successful business with operational runway extending into Q1 2026 and $341.4 million as of June 30, 2022, with an addition of $115.4 million from the sale of KRTX [Karuna Therapeutics] shares in the post-period.”

The company also has a strong clinical track record, Talbot said, and its wholly owned pipeline and royalties and stakes in programs from its Founded Entities give it a strong financial foundation.

“Our board is confident in the existing prospects for PureTech, which are built upon a well-funded balance sheet and strong Wholly Owned Pipeline," Talbot said. 

The K-6 filing indicates PureTech remains in an “offer period” until the October 6th announcement expires. During that period, Nektar can either announce a firm plan to make an offer or announce it doesn’t plan to make an offer.

Nektar indicated it holds the right to make or participate in an offer within the next six months, if the PureTech board agrees and if circumstances “materially change.”

In April, Nektar described a strategic reorganization plan that included slashing 70% of its workforce. The announcement came weeks after Bristol Myers Squibb shuttered the two companies’ clinical collaboration program on bladder cancer and renal cell carcinoma.

The strategic plan had three pillars, as described on a conference call by Nektar Pres. and CEO Howard W. Robin.

The first was focusing on “value-enhancing data and other milestones with our key programs that can drive increased shareholder value over time.”

The second was to right-size the organization; the third, to ensure Nektar had sufficient capital in place through 2025.

Although the BMS decision was a blow, with Nektar shares crashing 24% at the news, the company still has ongoing partnerships with Eli Lilly, Merck KGaA, Darmstadt, Germany, Fred Hutchinson Cancer Center, MD Anderson Cancer Center and Stanford University School of Medicine.

The BMS decision came after disappointing results from two Phase III trials of Nektar’s bempegaldesleukin with BMS’s checkpoint inhibitor Opdivo for bladder cancer and renal cell carcinoma. Two earlier studies, Phase III PIVOT-IO-001 and Pivot-12 in melanoma were halted after unsatisfactory results.

https://www.biospace.com/article/puretech-and-nektar-rumored-merger-called-off/

Amgen upped to Overweight from Equal Weight by Morgan Stanley

 Target to $279 from $257

https://finviz.com/quote.ashx?t=AMGN&p=d

Orthofix and SeaSpine to Combine in Merger of Equals

 

  • Highly complementary spine and orthopedics portfolios

  • One of the industry’s broadest biologics and regenerative technology offerings

  • Differentiated and synergistic enabling technologies

  • Meaningful cross-selling revenue synergies and cost savings

  • Financial strength to pursue growth investments without need for immediate equity financing

  • Expected to be adjusted EBITDA accretive to Orthofix by the second year following close including cost savings

  • Companies to host joint conference call and webcast today at 8:00 a.m. ET

Under the terms of the agreement, which was unanimously approved by the Boards of Directors of both companies, SeaSpine shareholders will receive 0.4163 shares of Orthofix common stock for each share of SeaSpine common stock owned. Following the close of the transaction, Orthofix shareholders will own approximately 56.5 percent of the combined company, and SeaSpine shareholders will own approximately 43.5 percent of the combined company, respectively, on a fully diluted basis.

Orthofix and SeaSpine will host a joint conference call and webcast today at 8:00 a.m. ET to discuss the merger.

The conference call can be accessed by dialing +1 (833) 927-1758 within the U.S. and +1 (929) 526-1599 for all other locations. The confirmation code is 867247. Participants should dial in 10 minutes prior to the scheduled start time.

A live webcast of the conference call and associated presentation materials will be available on the investor relations section of each company’s website at www.orthofix.com and www.seaspine.com.

https://finance.yahoo.com/news/orthofix-seaspine-combine-merger-equals-100000003.html

Albireo: Positive Topline Data from Phase 3 Trial in Alagille Syndrome

 

  • Highly statistically significant improvement in pruritus primary endpoint (p=0.002)

  • Significant reductions in key secondary endpoint of serum bile acid levels (p=0.001)

  • Substantial improvements in multiple sleep parameters

  • Well tolerated with low incidence of drug-related diarrhea, no discontinuations

  • Plans to immediately file in the U.S. and EU, adding to approved indication for PFIC

  • Conference call to be held today at 8:30am EDT

Albireo will host a conference call and live audio webcast at 8:30 a.m. EDT. To access the live conference call by phone, dial 1-877-407-0792 (domestic) or 1-201-689-8263 (international), and provide the access code 13733685. A live audio webcast will be accessible from the Investors page at ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo’s website for 3 months following the event.

Dice Psoriasis Pill Promises To Lead Its Class

 Dice Therapeutics (DICE) stock skyrocketed to a record high Tuesday after the biotech company unveiled promising early-stage test results for a psoriasis pill.

In premarket trading on today's stock market, shares of Dice stock soared 92.7% near 47.50.

Dice Chief Executive Kevin Judice says the results suggest Dice's DC-806 could be a best-in-class oral treatment for psoriasis.

After four weeks of treatment, patients showed a 43.7% decline in symptoms on a scale known as PASI, or psoriasis area and severity index. In comparison, placebo recipients had a 13.3% decline.

Now, the company is planning a midstage study beginning in the first half of 2023. Based on the promising data, Dice could also look at testing DC-806 in related diseases, Judice said in a written statement.

Dice Stock's Recent Yo-Yo

Dice's drug works by blocking interleukin-17, a substance in the body tied to inflammation.

The company tested DC-806 in three groups. Two groups of healthy volunteers received different dosages. Dice also showed its first proof-of-concept results in 32 patients with psoriasis. Of the latter group, eight patients received the highest dose and had a nearly 44% decline in symptoms.

In response, Dice stock topped its highest-ever point. Shares began trading in September 2021.

Dice noted the drug had "an excellent safety profile across all dose groups." There were no serious side effects, no incidents that prompted Dice to pull back the dosage, no treatment-related dropouts in the study and no clinically significant changes in patients' blood tests.


https://www.investors.com/news/technology/dice-stock-hits-record-high-as-investors-eye-possible-best-in-class-drug/

Roche: PRAME Antibody Evaluates PRAME Protein Expression In Suspected Melanoma

 Swiss drug major Roche (RHHBY) announced Tuesday the launch of Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from patients that may have melanoma.

Melanoma is an aggressive skin cancer that originates from melanocytes, which are cells in the skin and eyes that produce and contain melanin. When detected early, the 5-year survival rate is 99 percent.

The company noted that the PRAME (PReferentially expressed Antigen in MElanoma) protein is expressed in most melanomas. Due to this, the PRAME (EPR20330) Antibody is used as an aid to differentiate between benign and malignant lesions to help improve diagnostic decisions.

If PRAME expression is detected, this suggests that the lesion is malignant.

The first test that is used to evaluate a potential melanocytic lesion is a hematoxylin and eosin (H&E) stain of the patient's tissue sample. However, not all melanomas are easily diagnosed using H&E alone.

As per studies, detection of PRAME expression by immunohistochemistry or IHC complements findings from routinely used tests. In particularly challenging cases, use of PRAME IHC may highlight abnormal cells expressing the PRAME protein and provide more confidence in diagnosis of melanoma.

Roche noted that the PRAME (EPR20330) Antibody is fully automated on the full line of Roche BenchMark IHC/ISH instruments.

The company will present more information about PRAME at the International Academy of Pathology 2022 World Congress in Sydney, Australia on October 14.

https://www.nasdaq.com/articles/roche%3A-prame-epr20330-antibody-evaluates-prame-protein-expression-in-suspected-melanoma

UN spokesperson: 16 confirmed cholera deaths in Haiti

 There have been 16 confirmed deaths from cholera in Haiti and 32 confirmed cases, a United Nations spokesperson said on Tuesday, citing the latest figures from UN humanitarian workers there

“We are very, very concerned,” Margaret Harris of the World Health Organisation, who spoke at a news conference with the UN spokesperson, added with reference to cholera outbreaks in Haiti and beyond.

https://www.timeslive.co.za/news/world/2022-10-11-un-spokesperson-16-confirmed-cholera-deaths-in-haiti/