Thu, Dec. 8, 11:33 AM
- In a regulatory filing, Recro Pharma (REPH -5%) reports that it has amended its Purchase and Sale Agreement with Alkermes (ALKS +0.2%) related to a potential $10M milestone payment that will be triggered upon the filing of a New Drug Application (NDA) for intravenous (IV) meloxicam. If Recro exercises its option to defer payment, the milestone due Alkermes will be increased to $15M. This would increase the aggregate milestone due Alkermes to $45M upon NDA approval.
- Recro acquired global rights to the product candidate and a contract manufacturing facility from Alkermes in March of last year.
- Previously: Recro Pharma buys assets from Alkermes in a $170M deal (March 9, 2015)
Fri, Dec. 2, 4:35 PM
Wed, Nov. 2, 9:46 AM
- Alkermes (ALKS +0.7%) Q3 results: Revenues: $180.2M (+18.0%); Operating Loss: ($61.1M) (+21.1%); Net Loss: ($62.7M) (+22.6%); Loss Per Share: ($0.41) (+24.1%); Non-GAAP Loss Per Share: ($0.09) (+52.6%); Quick Assets: $624.6M (-21.8%).
- 2016 Guidance: GAAP Net Loss: ($230M) (unch); Non-GAAP Net Loss: ($20M) (unch); Loss Per Share: ($1.51) (unch); Non-GAAP Loss Per Share: ($0.13) (unch).
Wed, Nov. 2, 7:02 AM
Tue, Nov. 1, 5:30 PM
- ABC, ADP, AGN, ALKS, AMSC, ANTM, ARCC, ARCO, ASC, BABA, BAH, BDC, BG, BTE, CBB, CCJ, CDK, CDW, CEVA, CLH, CLX, CRL, CRTO, CSTE, DLPH, DNOW, DOC, EE, EL, EMES, FLWS, FUN, GLDD, GPT, HCN, HEP, HSIC, HST, HYH, INGR, INXN, IPI, JLL, KATE, MMP, MNTA, MVIS, NRZ, NS, NSM, NVMI, NWN, NYT, ODP, OMAM, ORBC, ORBK, OZM, PCRX, Q, SABR, SBGI, SE, SEP, SHOP, SJR, SNAK, SNR, SRE, STE, STWD, SUM, TEL, TGNA, TMHC, TOWR, TRP, TWX, VER, VMC, VOYA, VSI, WD, YELP, ZTS
Fri, Oct. 28, 1:02 PM
- United Therapeutics (NASDAQ:UTHR) upgraded to Buy from Neutral by Ladenburg Thalmann. Price target raised to $138 (18% upside) from $128.
- NeoGenomics (NASDAQ:NEO) upgraded to Buy from Neutral with a $10 (25% upside) price target by BTIG Research.
- Pacira Pharmaceuticals (NASDAQ:PCRX) upgraded to Market Perform from Underperform by BMO Capital. Price target raised to $36 (8% upside) from $35.
- Alkermes (NASDAQ:ALKS) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $78 (53% upside) from $51.
- McKesson (NYSE:MCK) downgraded to Neutral from Outperform by Baird. Price target lowered to $164 (34% upside) from $200. Also downgraded by Standpoint Research, Deutsche Bank and Leerink Swann.
- Community Health Systems (NYSE:CYH) downgraded to Underperform from Neutral by Baird. Price target lowered to $8 (47% upside) from $12.
- TeamHealth Holdings (NYSE:TMH) downgraded to Market Perform from Outperform by Leerink Swann. Price target raised to $43 (17% upside) from $40..
- ARIAD Pharmaceuticals (NASDAQ:ARIA) downgraded to Market Perform from Market Outperform by JMP Securities. Price target raised to $9.37 (7% upside) from $4.37.
- Vertex Pharmaceuticals (NASDAQ:VRTX) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $85 (8% upside) from $155.
- Teva Pharmaceutical Industries (NASDAQ:TEVA) downgraded to Neutral from Buy by Mizuho. Price target lowered to $45 (7% upside) from $64.
Fri, Oct. 21, 12:40 PM
Fri, Oct. 21, 11:19 AM
- Thinly traded nano cap Cerecor (CERC +16.7%) perks up on more than a 22x surge in volume, albeit on turnover of only 890K shares, as buyers spread the wealth stoked by Alkermes' (ALKS +33.5%) successful late-stage study of ALKS 5461 in major depressive disorder (MDD).
- Cerecor's lead product candidate is CERC-301, in Phase 2 development for the adjunctive treatment of MDD. Another mid-stage pipeline candidate for the same indication is CERC-501, a drug with a similar mechanism of action to ALKS 5461.
Fri, Oct. 21, 11:01 AM
Fri, Oct. 21, 10:22 AM
- Alkermes (ALKS +31.6%) jumps out of the blocks on double normal volume this morning in response to its successful Phase 3 study, FORWARD-5, of ALKS 5461 in major depressive disorder (MDD).
- JPMorgan: believes ALKS 5461 approvable in U.S. based on FORWARD-5 results and totality of overall study data and could be worth $18/share in incremental value.
- Goldman Sachs: reintroduced ALKS 5461 into valuation model assuming peak sales at over $700M. Sees a chance that the FDA will request another Phase 3 study to confirm results (two earlier Phase 3s, FORWARD-3 and FORWARD-4, failed). ALKS price target raised to $48 (16% downside risk) from $35.
- Leerink: ALKS 5461 has "reasonable chance" of FDA approval. Price target raised to $70 (23% upside) from $57.
- Cowen & Co.: rates stock Outperform. Price target under review.
- The success of FORWARD-5 surprised many analysts since two other Phase 3's, FORWARD-3 and FORWARD-4, failed based on the same primary endpoint due to a higher-than-expected placebo effect. Enrollment was increased in FORWARD-5 to compensate.
- Previously: Alkermes +50%; announces positive topline results from 5461 depression drug (Oct. 20)
Fri, Oct. 21, 9:18 AM
Thu, Oct. 20, 5:36 PM
Thu, Oct. 20, 4:09 PM
- Alkermes (NASDAQ:ALKS) announces positive topline results from FORWARD-5, the third phase 3 efficacy study to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder ("MDD") in patients with an inadequate response to standard antidepressant therapies.
- The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated.
- Management: “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461.”
- In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores (p=0.018). ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in 10-item MADRS (MADRS-10) scores compared to placebo (p=0.026). The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo.
- ALKS +50% to $65 post-market.
Tue, Oct. 18, 10:29 AM
- Biotech industry offers "attractive buying opportunities" given pre-election weakness, Jefferies says.
- Valuation multiples are near-historic lows; policy concerns are likely overstated.
- Firm recommends using weak sentiment to buy attractive names. Likes: Gilead (NASDAQ:GILD) and Celgene (NASDAQ:CELG) in large-caps, The Medicines Co. (NASDAQ:MDCO), Alkermes (NASDAQ:ALKS) and Vertex (NASDAQ:VRTX) in mid-caps. Alder Biopharmaceuticals (NASDAQ:ALDR), Cempra (NASDAQ:CEMP), Ultragenyx (NASDAQ:RARE) and Immunomedics (NASDAQ:IMMU) in small-caps.
Thu, Jul. 28, 11:15 AM
- Alkermes (ALKS -6.3%) Q2 results: Revenues: $195.2M (+28.9%); Operating Loss: ($47.1M) (+10.3%); Net Loss: ($47.2M) (-2.4%); Loss Per Share: ($0.31) (unch); Non-GAAP Loss Per Share: ($0.01) (+92.3%); Quick Assets: $677.7M (-15.2%).
- 2016 Guidance: GAAP Net Loss: ($230M); Non-GAAP Net Loss: ($20M); Loss Per Share: ($1.51); Non-GAAP Loss Per Share: ($0.13).
Thu, Jul. 28, 7:04 AM