BPC February 08 update

Biotech catalysts slated for rest of February; 1Q catalyst list updated; Biotech week in Review

Weekly watchlist

Evolus, Inc. (NASDAQ: EOLS) shares closed the week up 58% to $28.89, adding to last week’s gain of 23%. The company received approval from the FDA last Friday for Jeuveau for the improvement in the appearance of glabellar lines. 

Solid Biosciences (Nasdaq: SLDB) shares closed the week down 69% to $7.42 following disappointing data from its Phase 1/2 dose-ascending trial evaluating SGT-001 microdystrophin gene transfer for the treatment of Duchenne muscular dystrophy (DMD). Initial three-month biopsy data showed low levels of microdystrophin protein expression.

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) released preliminary data from its Phase 1/2 Champions trial evaluating SB-913, for the treatment of patients with Mucopolysaccharidosis Type II (MPS II). The goal of the treatment is to enable a patient's liver to produce a continuous supply of an enzyme required to break down or recycle the toxic buildup of glycosaminoglycans (GAGs). However, the company noted that while a small increase in the enzyme was evident it would not be insufficient to make a difference. Shares closed the week down 38% to $7.72.

MacroGenics, Inc. (NASDAQ: MGNX) shares soared to close Thursday up 130% to $25.60 before paring back some gains to close the week at $22.44, up 96% for the week. The company announced that its Phase 3 Sophia trial of margetuximab in HER2-positive metastatic breast cancer patients, met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to Herceptin plus chemotherapy.

uniQure N.V. (NASDAQ: QURE) shares closed Friday up 10% to $36.49 following the release of positive updated data from its ongoing Phase 2b trial of AMT-061 for the treatment of patients with severe and moderately severe hemophilia B. The data showed that levels of Factor IX (FIX) activity continue to be sustained in all three patients up to sixteen weeks after a single administration of AMT-061. Mean FIX activity increased to 38% of normal at 12 weeks after treatment.  

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Catalysts slated for the remaining three weeks of February are noted below. A significant number of catalysts remain on the calendar for release this quarter but only those certain to be announced this month are noted below. For a much broader look at catalysts due in February or March rather than those locked in for February, we suggest you refer back to the updated version of 1Q catalysts published two weeks ago. The list has been updated with stocks such as SLDB removed and KPTI added.

Next week sees the third major week of 4Q earnings while the key conference to watch will be the Genitourinary (GU) Cancers Symposium, a three-day meeting for GU malignancies, from February 14-16. Abstracts for the meeting will be released on Monday February 11 at 5pm EST at the Meeting Library.

Many eyes will be on the presentation by Merck (noted below) and its pivotal Phase 3 KEYNOTE-426 trial of Keytruda in combination with axitinib in patients with advanced or metastatic renal cell carcinoma. Data from the presentation has the potential to also impact Exelixis, Inc. (NASDAQ: EXEL) and Bristol-Myers Squibb Company (NYSE: BMY).

Drug Stage Catalyst Market Cap

BHC – Bausch Health Companies Inc.
DUOBRII (halobetasol propionate and tazarotene)
Psoriasis

PDUFA CRL issued June 18, 2018. Noted February 15, 2019 that the FDA has been unable to meet the PDUFA data of February 15, 2019 and expects a decision soon.
$8.3 billion

BHC – Bausch Health Companies Inc.
Loteprednol Gel 0.38%
Ocular Inflammation

PDUFA PDUFA date February 25, 2019.
$8.3 billion

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 interim data to be presented at 2019 ASCO-SITC February 28, 2019 1pm PST.
$44.5 million

JNJ – Johnson & Johnson
Esketamine
Treatment resistant depression

PDUFA priority review PDUFA estimate March 3, 2019 assuming priority review. FDA Advisory Committee Meeting February 12, 2019 voted 14-2 that benefits outweigh risks.
$366.4 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

PDUFA priority review PDUFA date under priority review April 6, 2019. Advisory Committee Meeting February 26, 2019 - 12:30pm. Briefing notes released February 22, 2019.
$307.8 million

MRK – Merck & Company Inc. (new)
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma

PDUFA priority review PDUFA date under priority review June 20, 2019.
$210 billion

MTFB – Motif Bio plc
Iclaprim
Acute bacterial skin and skin structure infections (ABSSSI)

CRL CRL issued February 14, 2019.
$28.6 million