These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Merrimack Pharmaceuticals (MACK), 28,591% surge in interest
- Kala Pharmaceuticals (KALA), 2,161% surge in interest
- Polarityte (PTE), 1,818% surge in interest
- Emergent Biosolutions (EBS), 731% surge in interest
- Theravance Bio (TBPH), 600% surge in interest
Pipeline and key clinical candidates for these companies:
Merrimack Pharmaceuticals is a biopharmaceutical company that is entitled to receive up to $450M in contingent milestone payments related to its sale of Onivyde to Ipsen S.A. in April 2017. These milestone payments would be payable by Ipsen upon approval by the FDA of Onivyde for certain additional clinical indications. Onivyde is already approved by the FDA in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Merrimack is also entitled to potentially receive up to $54.5M in contingent milestone payments related to its sale of anti-HER3 programs to Elevation Oncology in July 2019.
Kala is dedicated to the research, development and commercialization of therapies for rare diseases of the eye. Kala’s lead product candidate, KPI-012, is in clinical development for the treatment of persistent corneal epithelial defect, or PCED, a rare disease of impaired corneal healing, which has received orphan drug designation from the FDA. Kala is also targeting the potential development of KPI-012 for the treatment of Partial Limbal Stem Cell Deficiency and ocular manifestations of moderate-to-severe Sjögren’s and plans to initiate preclinical studies to evaluate the utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease.
PolarityTE is developing regenerative tissue products. PolarityTE’s first regenerative tissue product is SkinTE. PolarityTE has an open investigational new drug application for SkinTE with the FDA and is now pursuing the first of two pivotal studies on SkinTE needed to support a biologics license application, or BLA. SkinTE is available for investigational use only.
Emergent provides solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that the company develops and manufactures for governments and consumers. Emergent also offers a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers.
Theravance Biopharma developed FDA-approved Yupelri inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease, or COPD. Its pipeline of internally discovered programs is targeted to address significant unmet patient needs.
Recent news on these stocks:
November 10
Benchmark analyst Robert Wasserman downgraded Emergent BioSolutions to Hold from Buy and removed his prior price target after the company reported a 27% year-over-year decline in revenue compared to his estimate for just a 3% decrease. The revenue shortfall in the quarter comes primarily from the lack of option exercise by the U.S. Government for ACAM2000 smallpox vaccine and the company also revised financial guidance for FY22 downward due to the ACAM2000 shortfall. Emergent is continuing discussions with the U.S. related to the ACAM2000 purchase shortfall, which could be "a big boost to results" for Q4 or 2023, said Wasserman, but he is lowering his rating until the company can return to positive quarterly earnings comparisons.
November 9
Merrimack Pharmaceuticals shares surged after the company announced that partner Ipsen (IPSEY) issued a press release reporting its primary analysis of the results of its Phase III NAPOLI 3 trial of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin, or the "NALIRIFOX regimen," as a treatment of first line metastatic pancreatic ductal adenocarcinoma, or mPDAC. The Ipsen press release indicates that the trial "met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma and key secondary efficacy outcome of progression-free survival also showed significant improvement over the comparator arm.
PolarityTE confirmed that on November 1, it received an unsolicited, non-binding offer from Michael Brauser to acquire all of the outstanding common stock of the company not owned by him for $1.25 per share in cash. The board of the company and a special committee formed by the board will carefully review the terms and conditions of the offer to determine the course of action that it believes is in the best interest of the company and all company securityholders.
November 8
Kala Pharmaceuticals reported Q3 EPS of $19.25 vs ($21.41) last year, and reported Q3 revenue of $420,000 vs $3.067M last year. "We continue to advance our proprietary mesenchymal stem cell secretome platform and expect to submit an investigational new drug application with the U.S. Food and Drug Administration during the fourth quarter of 2022 for KPI-012 for the treatment of PCED," said Mark Iwicki, CEO of Kala. "Pending IND clearance, we plan to initiate our Phase 2/3 clinical trial in the fourth quarter of 2022, marking a significant step toward our goal of delivering the promise of MSC-S-based therapies to people living with rare and severe ocular diseases."
H.C. Wainwright analyst Douglas Tsao raised the firm’s price target on Theravance Biopharma to $19 from $12 and kept a Buy rating on the shares post the Q3 results.
About “Biotech Alert”
The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.
This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 15-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.
This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.
Published first on TheFly
