Dynavax $DVAX, in its regulatory filing, reported that FDA review team has asked for more information about its Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The company, however, dispelled fears by saying that a probe from the review team was in line with its expectations. The drug-maker is cooperating with the review team to resolve all remaining questions in order to make sure the completion of its review by the scheduled action date of December 15. Dynavax shares rallied nearly 20% following the clarity on the issue.

As a part of the broader R&D strategy, which is to improve the cash runaway rate and focus on a set of systems biology-derived oncology candidates, Merrimack Pharm $MACK announced downsizing 22% of its workforce, including President & CEO Robert Mulroy, who has resigned with an immediate effect. The company expects to save $200mn in operating costs over the next two years and have enough cash to fund operations for at least next 12 months as a result of the decision. It will record a one-time charge of $4.5 to $5mn in severance related expenses. Gary Crocker, who served as chairman, will take over as interim President and CEO until a permanent replacement is found.

Janssen’s psoriasis candidate guselkumab Shows Encouraging Last-Study Results-The results from Phase 3 clinical Trial, VOYAGE1, evaluating Janssen’s $JNJ guselkumab efficacy in comparison to AbbVie’s $ABBV HUMIRA (adalimumab) among adult patients with moderate-to-severe plaque psoriasis showed that the former is better. The data was presented over the weekend at the 25th European Academy of Dermatology and Venerology Congress in Vienna, Austria. GuselKumab was administered through subcutaneous injection at weeks 0 and 4 then every 8 weeks subsequently.

Aralez Introduces YOSPRALA in the U.S.-Aralez Pharmaceuticals $ARLZ launched YOSPRALA in the U.S. for secondary prevention of cardiovascular and cerebrovascular events for patients at risk of aspirin-linked gastric ulcers. The once-a-day dose is the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), in the U.S. YOSPRALA is being promoted by 110 sales representatives in the U.S. and is currently available in the wholesale chain.

Jazz Pharma Commences Rolling NDA for Leukemia Candidate Vyxeos-Jazz Pharmaceuticals $JAZZ initiated the rolling submission of its New Drug Application (NDA) to the FDA seeking approval for Vyxeos (cytarabine and daunorubicin liposome injection) for the treatment of acute myeloid leukemia (AML), a Breakthrough Therapy-designated indication. The company anticipates completing the filing in early 2017. The drug-maker took the rights to Vyxeos through its acquisition of Celator Pharmaceuticals, earlier in July.

Ironwood’s ZURAMPIC Now Available in U.S. Pharmacies-Ironwood Pharmaceuticals $IRWD announced that ZURAMPIC, a once-a-daily oral tablet taken in combination with a Xanthine oxidise inhibitor (XOI) for the treatment of hyperuricemia, is now  available in pharmacies throughout the U.S. Hyperuricemia is a condition  where high serum uric acid (sUA) levels in the blood are found, which is associated with gout in patients who have not achieved target sUA levels with an XOI alone.

GlobeImmune Climbs on Hopes of Phase 2 Data-Lightly traded nano-cap stock GlobeImmune Inc $GBIM gained 8% on Monday, continuing with its uptrend that started on September 21. The stock has vaulted 65% since then, mainly on optimism surrounding the positive 48-week data from a Phase 2 Clinical Trial evaluating GS-4774, a therapeutic HBV vaccine candidate being developed by Gilead Sciences ($GILD). The outcome will be presented at the Liver Meeting in Boston on November 14.

No approvals to report.

No patents to report.

AstraZeneca $AZN inked a deal with Allergan $AGN valued at $1.52bn in which the latter will buy rights to an antibody for Crohn’s disease. As per the terms of the deal, Allergan will pay $250mn upfront; however, it might have to pay up to $1.278bn over the course of 15 years, tied to potential sales of the antibody, branded as MEDI2070—an anti-IL-23 monoclonal antibody, which is at present under Phase 2b clinical development. The deal includes launch milestone payments up to $435mn and sales-based milestones of $725mn in addition to royalties.

NovaBay Pharmaceuticals $NBY pulled in $7mn from the early exercise of 3,673, 462 warrants issued in five earlier completed financings. It also expects to raise at least another $400k in October from the exercise of additional warrants. Most of the warrants were issued in an $11.791 private placement in May and August. Other warrants were issued in private deals, concluded in July 2011, March 2015, and October 2015. The stock closed at $4.10 on Friday.

Ra Pharmaceuticals has filed for an $86 million IPO. The company plans to list its shares on the NASDAQ under the ticker symbol RARX. Based in Cambridge, Massachusetts, Ra Pharmaceuticals is focusing on the development of small molecule therapies targeting rare blood disorders.

Heron Therapeutics $HRTX, in its recent regulatory filing, reported that three executives will be departing as part of the company’s realignment strategy following the FDA approval of SUSTOL (granisetron). The executive who will be departing are: Neil Clendeninn, PhD, SVP, Chief Medical Officer; Paul Marshall, SVP, Technical operation (both resigned on September 30) and Brian Drazba, VP, Finance and CFO will resign effective March 31st, 2017.

CTI BioPharma’s $CTIC, President & CEO, James Bianco, M.D, retired on Sunday. Director Richard Love will take over the reins on an interim basis until Mr. Bianco’s replacement is found.

NYSE- Intrexon (XON) shares were among the major gainers on the NYSE. The stock closed 3.64% higher. Puma Biotechnology (PBYI) shares were among the major losers on the NYSE. The stock closed 4.28% lower.
NASDAQ- SCYNEXIS (SCYX) shares were among the major gainers on the NASDAQ. The stock closed 17.57% higher. Concordia International (CXRX) ended the day 15.40% higher. Fulgent Genetics (FLGT) ended the day 12.69% higher. Dicerna Pharmaceuticals (DRNA) shares were among the major losers on the NASDAQ. The stock closed 10.88% lower. Loxo Oncology (LOXO) ended the day 8.52% lower. Adaptimmune Therapeutics (ADR) (ADAP) ended the day 6.10% lower.
NYSEMKT- Actinium Pharmaceuticals (ATNM) shares were among the major movers on the NYSEMKT. The stock closed 2.22% higher.
OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 6.67% higher.