Baird: Not surprised by upside pre-announcement from Tandem Diabetes

After Tandem Diabetes pre-announced better than expected Q3 revenue and an updated full-year view that implies Q4 revenue largely in line with consensus estimates, Baird analyst Jeff Johnson said he was not surprised by the upside and expects the company’s solid fundamentals to persist as U.S. growth remains strong and international revenue starts to contribute. However, he thinks the current valuation reflects this strength and maintains a Neutral rating and $47 price target on Tandem Diabetes shares.
https://thefly.com/landingPageNews.php?id=2795255

Cambrex to expand, invest at High Point, North Carolina site

Cambrex Corporation announced that it is to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina. Cambrex will acquire its currently leased 35,000 sq. ft. facility, as well as an adjacent 45,000 sq. ft. building which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development laboratories. The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing, analytical and chemical development. The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as expertise in technology transfer to commercial scale. At its High Point facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg in support of clinical trials from Phase I through to Phase III. The site is licensed with the US Drug Enforcement Administration to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.
https://thefly.com/landingPageNews.php?id=2795249

Humana, University of Houston announce long-term strategic partnership

Humana and the University of Houston announced a long-term strategic partnership to train the health care leaders of tomorrow with a focus on advancing population health, improving health outcomes and expanding the use of value-based payment models. Together, the two organizations will create the Humana Integrated Health System Sciences Institute at the University of Houston, which will unite the university’s new College of Medicine, as well as the existing colleges of Nursing, Pharmacy, Social Work and Optometry. A $15M gift over 10 years from Humana will help defray start-up and operational costs for the College of Medicine, as well as fund endowed chairs for each of the five colleges. The strategic collaboration is designed to graduate physicians, nurses, pharmacists and other health care professionals who are trained in population health and have a propensity for primary care and for working with the underserved. With its emphasis on underserved communities, the University of Houston and Humana partnership aligns with Humana’s Bold Goal of improving the health of the communities it serves 20 percent by 2020 by making it easier for people to achieve their best health. Humana is taking a population health approach to pursue this goal, while working to address social determinants of health such as food insecurity, social isolation and inadequate transportation.
https://thefly.com/landingPageNews.php?id=2795139

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.

https://www.biospace.com/article/fd1a-verastem-gets-fda-approval-for-leukemia-drug-will-make-it-immediately-available-to-patients/

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