Premarket Biotech Digest – CBMG Inks New Deal, IPCI Sued, SYRS Gets FDA Nod

Top Pick of the Day: GERN

Geron Corporation (GERN) stock picked up on the news that the company has agreed to a settlement related to a consolidated class-action securities lawsuit. The settlement will lead to the dismissal with prejudice of all claims against all defendants in the matter. It involves Geron paying $6.25 million in cash. Out of this, $6 million is payable by the company’s insurers while Geron will pay remaining $250,000.

The company stock jumped over 19 percent in its previous trading session, taking its Year to Date gain to 24 percent. Geron also recently announced positive interim update from two clinical trials of imetelstat drugs.

Focus Ticker: CBMG

Cellular Biomedicine Group Inc. (CBMG) announced its new strategic  research collaboration with GE Healthcare Life Sciences China. The collaboration pertains to co-developing certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing. The company stock reacted positively to the news, trimming its 12 months losses to 37 percent.

Cellular Biomedicine recently reported that its new Zhangjiang facility, together with an expanded Wuxi, and Beijing GMP-facilities, will have a combined 70,000 square feet for development and production.At their full capacity, the facilities could support the treatment of up to 10,000 cancer patients and 10,000 knee osteoarthritis patients per year.

Sector News

Intellipharmaceutics International (IPCI) that it is being sued by a consortium with regard to alleged patent infringement in the U.S. District Court for the District of Delaware. The case is related to the company’s  New Drug Application (NDA) filing for its Rexista product candidate (abuse-deterrent oxycodone hydrochloride extended release tablets) with the FDA. Consequently,  the FDA is stayed for 30 months from granting final approval to the Company’s Rexista abuse-deterrent oxycodone.

OncoMed Pharmaceuticals (OMED) announced that its the phase 2 demcizumab pancreatic cancer trial missed its primary endpoint.  demcizumab was being tested with two chemotherapy drugs in previously untreated metastatic pancreatic cancer. The company is collaborating with Celgene for the trials. However, the company has decided to discontinue the trials.


Repros Therapeutics (RPRX) announced that the FDA has decided to continue a partical clinical hold on its s Proellex drug for uterine fibroids, or tumors in the uterus. The FDA  plans to consult with its liver experts about the liver toxicity. The company plans to  submit additional information and a proposed clinical protocol within a month.

TherapeuticsMD (TXMD) announced that the company received a letter from the FDA stating that it has  identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. The letter pertains to the company’s new drug application (NDA) for TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia.

Deals and Collaborations

GB Sciences (GBLX) announced that it has inked a new deal with Kush Cups for producing cannabis-infused products in the state of Nevada. GB Sciences utilizes advanced propagation technology, raw tissue, and medical-grade clean rooms for growing cannabis.

Syros Pharmaceuticals (SYRS) reported that the FDA accepted the Company's Investigational New Drug (IND) application to advance SY-1365  into a Phase 1 clinical trial in patients with advanced solid tumor malignancies, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers. The company is on track to initiate the Phase 1 trial in second quarter.

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