BioXcel: FDA Extends Review for Schizophrenia and Bipolar Treatment

 PDUFA date extended by three months to April 5, 2022

No Additional Data Requested Following Meeting with FDA

 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

In connection with the FDA’s ongoing review, BioXcel Therapeutics responded to the agency’s information request pertaining to analyses of clinical data, and was recently informed the application would require additional time for review. As a result, the FDA extended the previously disclosed PDUFA date of January 5, 2022 to April 5, 2022. BioXcel Therapeutics and the FDA met on November 30. No additional data has been requested.

“Following our meeting with the FDA, we remain committed to working closely with the agency to facilitate a review of our NDA for BXCL501 and excited about making this potential therapy available to patients and caregivers as soon as possible,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “As we prepare for anticipated FDA approval, we are confident in BXCL501’s broad potential to treat the millions of patients suffering from agitation associated with schizophrenia and bipolar disorders.”

https://finance.yahoo.com/news/bioxcel-therapeutics-announces-extension-fda-120000584.html

BeyondSpring Gets Complete Response Letter

 BeyondSpring Pharmaceuticals (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form.

The FDA’s CRL indicated that the results of the single registrational trial (106 Phase 3) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

“BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy,” said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. “The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally.”

BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.

https://finance.yahoo.com/news/beyondspring-pharmaceuticals-receives-complete-response-130000921.html

Sensus in U.S. Distribution Agreement for TransDermal Infusion System

Sensus to Bring FDA-cleared Non-invasive Drug-delivery System and Treatment Alternative to Needles to Dermatologists Beginning [Immediately/Date]

Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces the signing of an exclusive U.S. distribution agreement with Mattioli Eng. Italia S.P.A. for its TransDermal Infusion System non-invasive drug delivery system. Sensus plans to begin marketing this System to dermatologists nationwide beginning immediately.

The TransDermal Infusion System is cleared by the U.S. Food and Drug Administration (FDA) for the local administration of ionic drug solutions into the body for medical purposes, and can be used as an alternative to injections. Sensus’ sales organization will market the system to dermatologists for skin rejuvenation treatments, pre-laser treatments, pre- and post-plastic surgery and other applications. In addition, Sensus plans to make rental programs and leasing facilities available, similar to current programs for its superficial radiation therapy and aesthetic lasers.

The System allows drugs to penetrate the skin’s innermost, hypodermic layer by increasing permeability. Faster than traditional iontophoresis, the TransDermal Infusion System allows delivery of drugs that are otherwise not able to be absorbed including Botox®, hyaluronic acid, lidocaine, collagen and others typically used in aesthetic procedures.

https://finance.yahoo.com/news/sensus-healthcare-signs-exclusive-u-133000521.html

immunogen upped to Buy from Hold by Jefferies

 Target to $12 from $7

https://finviz.com/quote.ashx?t=imgn

Ardelyx upped to Buy from Neutral by Ladenberg

 Target $6

https://finviz.com/quote.ashx?t=ardx

India's Serum Institute delivers first Novavax shot through COVAX

 Serum Institute of India has sent doses of COVID-19 vaccine to Indonesia, in its first export of the Novavax shot through the COVAX network, the Indian government said https://www.mea.gov.in/vaccine-supply.htm on Wednesday.

The world's biggest vaccine maker exported 137,500 doses of Covovax, as it calls the shot, to the Southeast Asian country last week.

Indonesia has approved the vaccine but India and the World Health Organization, which co-leads the COVAX vaccine-sharing network, have not.

https://www.marketscreener.com/quote/stock/NOVAVAX-INC-58256108/news/India-s-Serum-Institute-delivers-first-Novavax-shot-through-COVAX-37175069/

Sanofi to buy Origimm Biotechnology to boost vaccines business

 French healthcare company Sanofi has agreed to buy Austrian group Origimm Biotechnology in a move that Sanofi said would boost its vaccines business.

"The acquisition of Origimm further broadens our vaccines research and development pipeline with a first vaccine candidate against acne, a high medical need for millions of teenagers and adults," said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, on Wednesday.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Healthcare-group-Sanofi-to-buy-Origimm-Biotechnology-to-boost-vaccines-business-37175493/