13 Emerging Biotechs With Catalysts In 2017

Biotech stocks, which had a torrid 2016, can look ahead to the unfolding year with some hope, although given the quirky nature of the clinical trial outcomes, a recovery is still in question.

Wedbush has compiled a list of 13 emerging biotech stocks with catalysts in 2017.

1. Aimmune Therapeutics Inc AIMT

Catalysts

• Initiates RAMSES trial – Q117
• Last patient completes up-dosing in AR101 PALISADE trial – H117, with 70:30 probability and 0-15 percent stock upside or downside potential
• Pivotal Ph3 AR101 results from PALISADE trial – Q417, with 75:25 probability and 25-40 percent stock upside or downside potential

The firm reiterated its Outperform rating and $42 price target on Aimmune, which is a developer of treatments for food allergies.

2. Ascendant Resources Inc ASND

Catalysts

• Enrollment update for pivotal trial for TransCon hGH – H117, with 50:50 probability and 0-5 percent stock upside or downside potential
• Preclinical data for TransCon CNP – Q117, with 50:50 probability and 0-5 stock percent upside or downside potential
• Submit IND for TransCon PTH / hypoparathyroidism – Q217
• Submit IND for TransCon CNP / achondroplasia – Q417
• Potential announcement of U.S./ex-U.S. partnership for TC hGH – 2017, with 50:50 probability and 0-25 percent stock upside potential

Wedbush has an Outperform rating and a $31 price target on Ascendis.

3. BioMarin Pharmaceutical Inc. BMRN

Catalysts

• Submit BLA for Pegvaliase / PKU – Q117, with 70:30 probability and 0-10 percent stock upside or downside potential
• Full Ph1/2 results: BMN 270 FVIII/Hemophilia A gene therapy – Early January, with 60:40 probability and 0-15 percent stock upside or downside potential
• Advisory committee meeting for Brineura – Q117, with 60:40 probability and 0-10 percent stock upside or downside potential
• PDUFA date for Brineura (Cerliponase alfa) in CLN2 – April 27, with 65:35 probability and 0-10 percent stock upside or downside potential

The firm has a Neutral rating and a $102 price target on BioMarin.

4. Catabasis Pharmaceuticals Inc CATB

Catalysts

• Part B results Phase 1/2 CAT-1004 in DMD—12wk efficacy – Q117, with 50:50 probability and 5-25 percent stock upside or downside potential
• Data from the Phase 2a trial of CAT-2054 at medical mtg – 2017
• Initiate Phase 1 trial of CAT-4001 (safety, PK, PD) for ALS and FA – 2017

Webush has an Outperform rating and $46 price target for Catabasis.

5. Cohen & Steers Clsd-End Optuny Fnd, Inc. FOF

Catalysts

• Initiate Ph3 of SCS-Zuprata in ME-RVO (CLS-1003) – H117
• Pivotal Ph3 data for SCS-Zuprata in ME-NIU (CLS-1001) – Q417/Q118, with 60:40 probability and 10-40 percent stock upside or downside potential
• Potential Phase 1/2 data release for SCS-Zuprata in DME – H217, with 60:40 probability and 0-10 percent stock upside or downside potential
• Ph1/ 2 data for CLS-1002 in wet AMD – 2017, with 50:50 probability and 0-40 percent stock upside or downside potential

Webush has an Outperform rating and $28 price target on Clearside Biomedical.

6. Intercept Pharmaceuticals Inc ICPT

Catalysts

• INT-767 Phase 1 results – Q117, with 50:50 probability and 0-10 percent stock upside or downside potential
• Complete enrollment of Phase 3 REGENERATE trial, with 80:20 probability and 0-10 percent stock upside or downside potential
• Data from Phase 2 CONTROL(OCA w/ stain in NASH) trial, with 80:20 probability and 5-20 percent stock upside or downside potential
• Data from Phase 2 AESOP (PSC) trial, with 80:20 probability and 5-10 percent stock upside or downside potential

The firm has an Outperform rating and $224 price target for Intercept Pharma.

7. Lexicon Pharmaceuticals, Inc. LXRX

Catalysts

• Early indication that FDA may consider reviewing T1D – Q117, with 50:50 probability and 0-100 percent stock upside or downside potential
• FDA PDUFA date for telotristat ethyl – February 28, with 90:10 probability and 0-15 percent stock upside or downside potential
• Potential U.S. launch of telotristat ethyl – Q217, with 90:10 probability and 0-10 percent stock upside or downside potential
• Potential EU approval of telotristat ethyl – 2017, with 80:20 probability and 0-10 percent stock upside or downside potential

Webush has an Outperform rating and $33 price target on shares of Lexicon.

8. Omeros Corporation OMER

Catalysts

• Additional data from Phase 2 trial of OMS721/aHUS/TMAs – 2017, with 75:25 probability and 0-10 percent stock upside or downside potential
• OMS721 data in aHUS at ISN Word Congress of Nephology – April
• OMS721 data in Renal Diseases at ERA-EDTA (Spain) – June 3-6

Wedbush has an Outperform rating and $47 price target for shares of Omeros.

9. Pacira Pharmaceuticals Inc PCRX

Catalysts

• Symphony Health EXPAREL estimate for December/Q4:16 – January 25
• Potential regional exUS EXPAREL partnership(s) – 2017, with 90:10 probability and 10-20 percent stock upside or downside potential
• IR-RCT¥ EXPAREL knee active comparator trial data release – Q117, with 60-40 probability and 10-20 percent stock upside or downside potential
• Data release from two Ph3 Nerve Block Trials – Q117, with 80-20 probability and 10-40 percent stock upside or downside potential

The firm has an Outperform rating and $89 price target on Pacira Pharma.

10. Regulus Therapeutics Inc RGLS

Catalysts

• Potential removal of FDA clinical hold on RG-101 – Q117, with 60:40 probability and 5-40 percent stock upside or downside potential
• Results from Phase 2 RG-101/GSK-175 trial – Q117, , with 50:50 probability and 0-15 percent stock upside or downside potential
• Results from MAD study for RG-012 in HV – H117, with 50:50 probability and 0-5 percent stock upside or downside potential
• Phase 2 HERA study in Alport resumes – H217

Wedbush has an Outperform rating and $13 price target for Regulus.

11. Sangamo Biosciences, Inc. SGMO

Catalysts

• Updated data from SB-728-1101 Cohort 3 HIV study – 2017
• Data from Phase 1 SB-728-mR-HSPC HIV program – 2017
• Preliminary data from SB-FIX / Hemophilia B & SB AAV-FVIII – 2017/H118, with 50:50 probability and 20-15 percent stock upside potential or 15-20 percent downside potential

Wedbush has a Neutral rating and $4 price target on Sangamo.

12. United Therapeutics Corporation UTHR

Catalysts

• Potential US sNDA approval for RemoSync (possibly April) – 2017, with 50:50 probability and 10-25 percent stock upside or downside potential
• Launch of RemoSync (Remodulin implantable pump) – 2017, with 50:50 probability and 0-10 percent stock upside or downside potential
• Initiate Phase 2/3 trial of eNOS gene therapy – 2017
• FREEDOM-EV potentially completes enrollment – 2017, with 75:25 probability and 0-10 percent stock upside or downside potential

The firm has an Outperform rating and $229 price target on United Therapeutics.

13. XOMA Corporation XOMA

Catalysts

• Milestone payment to Xoma for $10 million – Q117; with 50:50 probability and a 0-10 percent stock upside or downside potential
• Out licensing of IL-2 mAb program for immuno-oncology – Q117, ; with 50:50 probability and a 0-10 percent stock upside or downside potential
• Updated data from Ph2 for XOMA 358 in CHI and PBS – H117, with 50:50 probability and a 0-15 percent stock upside potential or 0-10 percent downside potential
• Initiation of a multi-dose trial of XOMA 358 in CHI – 2017

Wedbush rates XOMA Neutral, with a $14 price target.