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Nano-cap stock, Cerecor $CERC gained sharply on Friday amid heavy trading volume in response to Alkermes’ $ALKS successful late-stage clinical trial of ALKS 5461 in major depressive disorder (MDD). Cerecor’s lead product candidate is CERC-301, going through investigations under Phase 2 development for the adjunctive treatment of MDD. Another mid-stage pipeline candidate for the same indication is CERC-501, a treatment with a similar mechanism of action to ALKS 5461.

FDA ready to review Newron’s resubmitted NDA for Xadago-Newron Pharmaceutical $NWPHF announced that the FDA has accepted to review its resubmitted New Drug Application (NDA) seeking approval of Xadago (safinamide) as add-on therapy in both early to mid-stage Parkinson’s disease (PD) patients who are inadequately managed on their current therapy. The action date is March 21, 2017.  The company received a Complete Response Letter (CRL) on March 28, 2016, apropos its original filing.

 FDA to review Bristol-Myers Marketing application for Opdivo meant for treating bladder cancer-The FDA accepted to review Bristol-Myers Squibb’s $BMY supplemental Biologic s License Application (sBLA) seeking approval for Opdivo (nivolumab) for the treatment of patients with locally advanced unresectable or or metastatic urothelial carcinoma that has progressed on or after platinum-based chemotherapy, a Breakthrough Therapy indication. The agency's action date is March 2, 2017. The data backing the filing was generated in the Phase 2 clinical trial, Checkmate-275, which demonstrated a 19.6% objective response rate in patients treated with Opdivo.

 Analysts bullish on Alkermes following successful late-stage study of antidepressant candidate-Alkermes $ALKS soared on Friday amid heavy trading volume in response to its successful Phase 3 clinical trial, FORWARD-5 of ALKS 5461 for treatment of patients with major depressive disorder (MDD). JP Morgan expects ALKS 5461 to get approved in the U.S. based on FORWARD-5 results and totality of overall data. Leerink also gives the treatment a “reasonable chance” of FDA approval with a 23% upside potential to $70.

 Merck's immunotherapy drug succeeds in key bladder cancer trial-A phase 3 study, KEYNOTE-045, evaluating Merck’s $MRK PD-1 inhibitor KEYTRUDA (pembrolizumzb) in treatment –experienced patients with advance urothelial cancer has been concluded early after the independent Data Monitoring Committee determined that the clinical trial met its primary endpoint of overall survival (OS). KEYNOTE-045 is a 542-participant subject randomized study that assessed KEYTRUDA as monotherapy compared to investigator choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced/unresectable urothelial cancer that has progressed following platinum-based chemo.

 Moleculin reports ‘positive development’ for Annamycin-Moleculin Biotech $MBRX, in its investor update, said that it observed “positive development” for lead drug candidate Annamycin. Chairman and CEO, Wally Kemp said that the company will be in position to use the Annamycin inventory of licensee Dermin for its clinical trials thereby reducing its planned costs for its mid-stage clinical trials lined-up next year.

The FDA approved Merck’s $MRK bezlotoxumab, labelled as ZINPLAVA, to reduce the recurrence of Clostridium difficile (C. diff) infection (CDI) in adult patients who are receiving antibacterial treatment and are at a high risk of CDI recurrence. ZINPLAVA should be taken in combination with antibacterial therapy since it is not indicated for the treatment of CDI.

No patents to report.

In a special meeting held last week, Alere shareholders, $ALR, unsurprisingly, voted overwhelmingly in favour of a merger with Abbot $ABT. During the meeting, more than 98% cast their votes, representing 77% of the company’s outstanding shares. They backed $ABT’s $56 a share transaction. The company first announced the merger deal earlier in January; however, things went off the track after a spate of problems arose at Alere, including dodgy billing practices, inappropriate revenue recognition and a government inquiry into its marketing and billing practices. The firms then agree to engage a mediator to settle their differences.

Northwest Biotherapeutics $NWBO plunged on Friday amid heavy trading volume in response to its announcement that it has signed an agreement with an institutional investor for the direct placement of up to 14 million shares of common stock at $0.38, representing a discount of roughly 30% to Thursday’s close of $0.5384. The closing date is October 26. The stock lost more than 96% since July 2015.

PTC Therapeutics $PTCT announced that Roche $RHHBY has begun a Phase 2 study, SUNFISH, evaluating RG7916 in pediatric and adult patients with Type 2/3 spinal muscular atrophy (SMA). The first part of the trial will assess the safety and tolerability of escalating doses of RG7916 in about 36 subjects. After the optimal dose is determined, the study will advance into a pivotal second stage to evaluate efficacy for up to 24 months followed by an open-label extension. The transition will generate $20 million milestone payment for PTC.

No secondary offerings to report.

CollPlant has filed for a $25 million IPO. The company plans to list its shares on the NASDAQ under the ticker symbol CLGN. Based in Ness-Ziona, Israel, CollPlant is a clinical-stage biotechnology company focusing on regenerative medicine for tissue repair.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Abeona Therapeutics $ABEO Cantor Fitzgerald Reiterate Buy $21 N/A
Acura Pharmaceuticals $ACUR FBR & Co. Reiterate Outperform $10 N/A
Aerie Pharmaceuticals $AERI RBC Capital Markets Reiterate Outperform $55 N/A
Alkermes Plc $ALKS JPMorgan Chase & Co. Upgrade/Price Target Raised From Neutral to Overweight From $51 to $78 N/A
Alkermes Plc $ALKS Morgan Stanley Upgrade From Underweight to Equal Weight $62 N/A
Alkermes Plc $ALKS Jefferies Group Price Target Raised Buy From $62 to $70 N/A
Alkermes Plc $ALKS Leerink Swann Price Target Raised Outperform From $57 to $70 N/A
Alkermes Plc $ALKS Credit Suisse Group Price Target Raised Outperform From $52 to $70 N/A
AveXis $AVXS Bank of America Corp. Initiation Buy N/A N/A
BioDelivery Sciences International $BDSI Roth Capital Price Target Set Buy $7 N/A
CytoKinetics $CYTK Roth Capital Reiterate Buy $22 N/A
Intellipharmaceutics International $IPCI Maxim Group Reiterate Buy $6 N/A
Mallincrkodt $MNK Wells Fargo Co. Price Target Cut Outperform From $88.50 to $83.50 N/A
Intellia Therapeutics $NTLA Wedbush Reiterate Outperform $38 N/A
NeuroMetrix $NURO Rodman & Renshaw Reiterate Buy $4.50 N/A
Omeros Corporation $OMER Wedbush Reiterate Outperform $56 N/A
Ultragenyx Pharmaceutical $RARE Canaccord Genuity Price Target Set Buy $120 N/A
Synergy Pharmaceuticals $SGYP Canaccord Genuity Reiterate Buy $13 $13.50
Theravance Biopharma $TBPH Leerink Swann Price Target Set Buy $35 N/A
Vertex Pharmaceuticals $VRTX Jefferies Group Reiterate Buy $105 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 1,800 shares at $9.38. The total value of the transaction was $16,884. Dr. Frost now owns 160,240,143 shares of OPK.

Prothena Corporation $PRTA- Gene G. Kinney, President & CEO, sold 20,619 shares in two separate transactions. Kinney sold 14,785 shares at $55.08; and 5,834 shares at $55.15. Kinney still owns 2,793 shares of PRTA.

United Therapeutics $UTHR- Martine A. Rothblatt, Chairman & CEO, sold 1,282 shares at $113.30. The total value of the transaction was $145,249. Rothblatt still owns 140 shares of UTHR.

UltraGenyx Pharmaceutical $RARE- Shalini Sharp, CFO & Vice President, sold 12,000 shares at $61.40. The total value of the transaction was $736,820. Sharp still owns 45,387 shares of RARE.

Concordia International $CXRX CEO Mark Thompson announced on Friday that he intends to resign as soon as a successor is appointed, citing an “ideal time for a leadership change. In addition, he will also step down as Chairman when a replacement is named. The stock nosedived 95% of their value over the past 12 months.

NYSE- Lannett Company $LCI shares were among the major movers on the NYSE. The stock closed 2.95% lower.

NASDAQ- Alkermes $ALKS shares were among the major gainers on the NASDAQ. The stock closed 27.83% higher. Pernix Therapeutics Holdings $PTX ended the day 18.71% higher. Intellia Therapeutics $NTLA ended the day 10.59% higher. Quotient $QTNT shares were among the major losers on the NASDAQ. The stock closed 8.83% lower. Affimed $AFMD ended the day 8% lower. Rigel Pharmaceuticals $RIGL ended the day 5.13% lower.

NYSEMKT- Actinium Pharmaceuticals $ATNM shares were among the major movers on the NYSEMKT. The stock closed 1.9% higher.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 15.25% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
BeiGene $BGNE - -12.7% 6
Bellerophon Therapeutics $BLPH 0.8% -17.1% 3
Bellicum Pharmaceuticals $BLCM 14.6% 5% 9
Bioblast Pharma $ORPN 2.1% -10.9% 3
BioCryst Pharmaceuticals $BCRX 10.9% 1.4% 9
BioDelivery Sciences International $BDSI 15.1% -2.6% 9
Biogen $BIIB 1.1% 6.4% 2