Pfizer Gets FDA Priority Review of Braftovi/Erbitux in Colorectal Cancer

Pfizer on Wednesday said the U.S. Food and Drug Administration accepted and granted priority review to a supplemental new drug application for Braftovi in combination with Erbitux in a form of colorectal cancer.

The New York drug maker said the agency set a target action date in April 2020.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Pfizer said the designation covers the combination in patients with advanced BRAF(V600E)-mutant metastatic colorectal cancer, following one or two lines of therapy.

The company said the designation is based on a phase 3 study that evaluated the efficacy and safety of the combination with or without Mektovi and showed improvements in overall survival and objective response rates for both compared to Erbitux plus irinotecan-containing regimens.

Pfizer has exclusive rights to Braftovi in the U.S. and Canada.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-Gets-FDA-Priority-Review-of-Braftovi-Erbitux-in-Colorectal-Cancer-29745523/

Epizyme up 12% after advisory committee nod on tazemetostat

Epizyme (EPZM +11.7%) touched $25.00 (+37%) after trading resumed following the FDA advisory committee meeting on tazemetostat but could hold the gain. Volume is closing in on 1.6M shares, up two-fold.

In an unanimous 11-0 vote, the committee backed approval for epithelioid sarcoma.

https://seekingalpha.com/news/3527217-epizyme-up-12-after-advisory-committee-nod-on-tazemetostat

Minerva Neurosciences Topline Results of Major Depression Phase 2b Trial

• MIN-117 study did not meet its primary (MADRS) and key secondary (HAM-A) endpoints
• MIN-117 was generally well-tolerated with a safety profile comparable to placebo
• Company hosted conference call at 5:00 p.m. today.  Minerva held a conference call and live audio webcast on December 18, 2019 at 5:00 p.m. Eastern Time.  To participate, please dial (877) 312-5845 for domestic callers or (765) 507-2618 for international callers and refer to conference ID number 3296395.  The live webcast can also be accessed under “Events and Presentations” in the Investors and Media section of Minerva’s website at ir.minervaneurosciences.com.  The archived webcast will be available on the website beginning approximately two hours after the event for 90 days.

https://www.globenewswire.com/news-release/2019/12/18/1962474/0/en/Minerva-Neurosciences-Reports-Topline-Results-From-Phase-2b-Trial-of-MIN-117-in-Major-Depressive-Disorder.html

89bio reports Q3 results

89bio (NASDAQ:ETNB): Q3 GAAP EPS of -$30.63.

Cash, cash equivalents and marketable securities $113.8M including gross proceeds from its IPO.

Press Release

https://seekingalpha.com/news/3527242-89bio-reports-q3-results

Arcus Bio to collaborate with Roche on two cancer studies

Arcus Biosciences (NYSE:RCUS) and Roche (OTCQX:RHHBY) will collaborate on two clinical trials, in third-line metastatic colorectal cancer (CRC) and first-line metastatic pancreatic cancer.

The CRC study will compare the combination of AB928, Tecentriq (atezolizumab) and Bayer’s (OTCPK:BAYRY) Stivarga (regorafenib) against atezolizumab + regorafenib.

The pancreatic cancer study will compare AB028 + atezolizumab and chemo agent gemcitabine/nab-paclitaxel [Bristol-Myers Squibb’s (NYSE:BMY) Abraxane] versus gemcitabine/nab-paclitaxel.

Each company is supplying product for the jointly funded studies.

AB928 is a dual adenosine A_2aR/A_2bR receptor antagonist designed to inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes. In other words, it is designed to block adenosine’s effect on suppressing the immune response to cancer cells.

https://seekingalpha.com/news/3527252-arcus-bio-to-collaborate-roche-on-two-cancer-studies

Bristol files U.S. application for CAR T for treatment-resistant lymphoma

Bristol-Myers Squibb (NYSE:BMY) has submitted its marketing application to the FDA seeking approval of CAR T therapy lisocabtagene maraleucel (liso-cel) (formerly JCAR017) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) who have received at least two prior therapies.

https://seekingalpha.com/news/3527256-bristol-myers-squibb-files-u-s-application-for-car-t-for-treatment-resistant-lbcl

Illumina to pay up to $34M to extend offer for Pacific Bio

Illumina (NASDAQ:ILMN) has notified Pacific Biosciences (NASDAQ:PACB) that it has exercised its right to extend the deadline of acquisition offer to March 31, 2020.

As stipulated in the agreement, it will pay PACB $6M no later than January 2, 2020, $22M no later than March 2, 2020 and $6M no later than March 2, 2020. The monies are repayable without interest if the merger agreement is terminated and PACB enters into a certain change-of-control agreement with a third party within two years or raises at lease $100M in new capital in a single transaction.

The companies are facing regulatory opposition to the tie-up in several jurisdictions over concerns that it will lessen competition.

https://seekingalpha.com/news/3527265-illumina-to-pay-up-to-34m-to-extend-offer-for-pacific-bio