Tuesday, September 25, 2018
Medidata price target lowered to $91 from $98 at RBC Capital
RBC Capital analyst George Hill lowered his price target on Medidata (MDSO) to $91, saying his revenue projections are now slightly lower than previously based on the increasing competition in ancillary services. The analyst cites Veeva’s (VEEV) recent announcement of a consolidated CDMS solution, IQVIA’s (IQV) expansion of its partnership with Salesforce to grow its offerings in clinical technology solutions, and LabCorp’s (LH) Covance unit launching a new technology suite earlier this year. Hill contends that while Medidata still has the lead in market share and product development for the clinical trial IT market, keeping an Outperform rating on the stock in the long run, he also warns that the product announcements from competitors could lengthen the company’s sales cycle.
https://thefly.com/landingPageNews.php?id=2795153
Verastem Gets FDA OK for Leukemia Med, To Be Immediately Available to Patients
Shares of Verastem closed out Monday trading on a positive note and continues to climb in the premarket following the greenlight for leukemia drug Copiktra, an inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.
The U.S. Food and Drug Administration (FDA) approved Copiktra (duvelisib) as a third-line treatment for adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Verastem said that Copiktra also received accelerated approval as a second-line treatment for adult patients with relapsed or refractory follicular lymphoma (FL). The indication in FL is approved under accelerated approval based on overall response rate, the company said. Verastem said continued approval “may be contingent upon verification and description of clinical benefit in confirmatory trials.”
Robert Forrester, president and chief executive officer of Verastem Oncology, said the approval of Copiktra demonstrates that the company is delivering on its commitment to cancer patients by bringing a new oral treatment to market. Forrester added that the company is pleased to be able to introduce the newly approved drug at the end of National Blood Cancer Awareness Month. Verastem said that Copiktra will immediately be available for patients in the United States. Joseph Lobacki, Verastem’s chief commercial officer said that in preparation for the launch of Copiktra, Verastem has assembled an experienced commercial team and established a distribution network.
Lymphoma is the most common blood cancer, and CLL/SLL and FL are common types of indolent non-Hodgkin’s lymphomas. There are an estimated 681,000 people living with non-Hodgkin’s lymphoma in the US alone, including nearly 350,000 cases of CLL/SLL or FL, Verastem said. Many of these patients will eventually relapse or develop refractory diseases.
“At Verastem Oncology, we are driven by the strength and courage of those battling cancer, and we are committed to advancing therapies such as Copiktra with the potential to make a significant impact for patients, their caregivers and physicians. We are immensely grateful to the many patients who participated in the duvelisib clinical trial program over the years leading to this pivotal moment,” Forrester said in a statement.
Approval for Clopiktra was based on positive Phase III trial results that showed the medication demonstrated a superiorprogression-freee survival over ofatumumab (Novartis’Arzerra), a standard of care treatment for CLL. Trial data showed that patients taking Copiktra achieved a statistically significant improvement in median progression free survival of 13.3 months. That was compared to 9.9 months for patients taking ofatumumab. At the time, the company said those numbers represent a 48 percent reduction in the risk of progression or death.
Verastem acquired Copiktra in 2016 from Infinity Pharmaceuticals, who gained it from AbbVie.
“We are excited to offer a new treatment that can allow patients to manage their disease with an oral monotherapy,” CCO Lobacki said in a statement.
While Copiktra will be available immediately, the drug does come with a Boxed Warning regarding four fatal and/ or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. The company said it is implementing an informational risk evaluation and mitigation strategy to provide appropriate dosing and safety information to support management of the medication. The medication also associated with adverse reactions that could require dose reduction, treatment delay or discontinuation of the medication, Verastem added. The most common adverse reactions during clinical trials were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. The company also noted that it will provide an assistance program to help patients have access to the medication.
AzurRx BioPharma price target raised to $8 from $6 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for AzurRx BioPharma to $8 after the company announced that the Phase 2a trial of MS1819 in chronic pancreatitis patients with exocrine pancreatic insufficiency met both primary and secondary endpoints. Importantly, the efficacy demonstrated by MS1819 is comparable to that of the porcine-derived pancrelipase currently on the market, such as Creon, Selvaraju tells investors in a research note. He views the data as “very encouraging” and reiterates a Buy rating on AzurRx.
https://thefly.com/landingPageNews.php?id=2794981
Encompass Health to create new south central region
Encompass Health announced the intention to create, effective Jan. 1, 2019, a region for its inpatient rehabilitation segment to accommodate growth in the number of hospitals. The new south central region will include the states of Alabama, Arkansas, Louisiana, Mississippi and Oklahoma. This realignment will increase the number of regions from six to seven. Encompass Health has named Brad Kennedy as president of its south central region. Kennedy has served as a vice president in Encompass Health’s central region since May 2016 and previously served as CEO of HealthSouth Rehabilitation Hospital – North in Memphis, Tennessee, and HealthSouth Rehabilitation Hospital of Cincinnati in Ohio. His new role goes into effect Jan. 1, 2019.
https://thefly.com/landingPageNews.php?id=2794985
Verastem price target raised to $15 from $10 at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth raised his price target for Verastem to $15 after the FDA approved the company’s lead product, Copiktra , for the treatment of third-line chronic lympocytic leukemia, small lympocytic leukemia, and follicular lymphoma. Not unexpectedly, the FDA has included a boxed warning highlighting the increased risk of serious infections, diarrhea, and colitis with Copiktra, the analyst adds. He expects Copiktra to generate revenues of $178M for these three indications by 2025 and keeps a Buy rating on Verastem.
https://thefly.com/landingPageNews.php?id=2794987
Cidara Therapeutics: Cidara granted FDA QIDP, Fast Track Designations
Cidara Therapeutics announced that the FDA has granted both Qualified Infectious Disease Product, or QIDP, and Fast Track designations for the company’s prophylaxis development program for lead antifungal product candidate, rezafungin for injection. Specifically, the QIDP designation is for the development of rezafungin for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Cidara previously announced QIDP designation for rezafungin for the treatment of invasive fungal infections caused by Candida.
https://thefly.com/landingPageNews.php?id=2795025
Nemaura Medical’s sugarBEAT could be used without finger stick
Nemaura Medical announced data indicating sugarBEAT could potentially be used as an adjunctive CGM without the need for finger-stick calibration. Nemaura retrospectively evaluated a portion of previously completed clinical data for 75 patients, using a refined factory calibration constant, based upon newly developed algorithms. 66% of patches worn by 92% of the patients generating 9,863 paired data points were evaluated, with 58% of these paired data points giving a MARD of 13.61%. Nemaura further noted 73% of these paired data points gave a MARD of 17.83%. Nemaura is currently undertaking additional data analysis, to potentially allow sugarBEAT to be used with zero or reduced frequency finger-stick calibration. SugarBEAT is anticipated to launch in the UK in the coming months, and is intended to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics.
https://thefly.com/landingPageNews.php?id=2795063
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