BPC April 13 update

Biotech Stock Week in Review ~ April 13, 2017; Upcoming mainly April/May 2Q catalysts

Weekly watchlist

Despite the shortened trading week and a lull in biotech news hitting the screens, there were still a number significant events to hit over the week, of which five are highlighted below:

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced Tuesday that the FDA approved INGREZZA for the first and only FDA approved product for the treatment of adults with tardive dyskinesia (TD). Investors were impressed with the lack of a black box safety label and sent shares higher to close the week up 31% at $53.39. Potential competitor, Teva Pharmaceutical Industries (NYSE:TEVA) has its key drug, Austedo, set for a PDUFA date of August 30, 2017. However, Austedo, only just recently approved for the treatment of chorea associated with Huntington’s disease (HD), has a black box warning for depression and suicide, which should give Neurocrine a clear advantage even if Austedo is approved.

Axovant Sciences (NYSE: AXON) announced Monday that David Hung was named as its new CEO. Hung is best known as founder and CEO of Medivation, which was acquired by Pfizer for $14 billion in September 2016. Investors, no doubt looking for similar fortunes with his role at Axovant, sent shares higher to close Monday up 22% to $18.54. Despite a $100m public offering the following day, the company’s share price continued its march north, closing the week at $22, up 45% for the week.

A number of other companies announced public offerings this last week. While Axovant was a notable exception, most companies saw a steep sell-off of their shares with the offerings priced at a significant discount, none more evident than Sorrento Therapeutics, Inc. (NASDAQ: SRNE) which saw its shares plunge on Thursday by 39% to $1.80 following the pricing of its public offering of 23.6m shares at a price of $2 per share, a substantial discount from Wednesday’s close of $2.96.

On the clinical data front, the major mover was OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), which saw its shares plummet 45% from last week to $4.84. The company announced that its Phase 2 YOSEMITE trial of demcizumab in combination with Abraxane plus gemcitabine in previously untreated patients with metastatic pancreatic cancer, did not meet the primary endpoint of progression-free survival. To make matters worse, OncoMed also announced that its partner Bayer Pharma will not exercise its option to license the first-in-class Wnt pathway inhibitors vantictumab and ipafricept.

TherapeuticsMD, Inc. (NYSE MKT: TXMD) shares closed the week down 28% to $5.51 following its announcement that the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments for its New Drug Application (NDA) for TX-004HR, for the treatment of moderate to severe dyspareunia (pain during intercourse). Few other details were given as to the severity of the deficiencies, so for the time being the original PDUFA date of May 7, 2017 remains. However, one might garner that there is greater than an even chance of the date being extended given the news released. 

Upcoming Catalysts below (most due within the next THREE weeks - ALDR and SAGE exceptions):

Drug Stage Catalyst

Frequent episodic migraine

Phase 3 Phase 3 PROMISE 1 top-line data released June 27, 2017, Primary and key secondary endpoints met but competitive concerns raised.

Endometrial cancer

Phase 3 Phase 3 trial did not meet primary endpoint - May 1, 2017.

Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 2 Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.

Cerliponase alfa
Batten Disease

Approved PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.

Tourette syndrome - juvenile

Phase 2 Phase 2 data released May 23 - primary endpoint not met.

Alzheimer's disease

Phase 2 Phase 2 data released May 1, 2017 - primary endpoint not met.


Phase 3 Phase 3 data released September 12, 2017 - primary endpoint not met.

Moderate-to-severe vaginal pain

CRL CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data. Meeting with FDA planned for November 3, 2017 with NDA to be resubmitted shortly after meeting.