BPC March 22 update

8 Biotech catalysts slated for the final week of March; Biotech week in review

Weekly watchlist

The last week of 1Q 2019 sees a number of companies set to release clinical data. It is not uncommon, however, to see companies miss their timeline guidance by a few days so it is quite possible that not all will readout this coming week. From the list on the BioPharmCatalyst FDA Calendar, we have taken eight events for our watch list. All are slated for next week, the only exception being ticker ALDX, which is slated for data in “early 2019”.

First, let’s review the week that was with key price moving events.

Dermira, Inc. (NASDAQ: DERM) announced Monday that its Phase 2b trial of lebrikizumab, in adult patients with moderate-to-severe atopic dermatitis, met the primary endpoint, demonstrating greater improvements in the Eczema Area and Severity Index (EASI) score compared to placebo. Shares closed the week up 90% to $12.99.

Aerpio Pharmaceuticals, Inc. (Nasdaq:ARPO) announced also on Monday that its Phase 2b trial of AKB-9778, for patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), did not meet the primary endpoint. Shares slumped to close the week down 77% to $1.12.

Biogen (Nasdaq: BIIB) announced Thursday the discontinuation of Phase 3 trials, Engage and Emerge, evaluating aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. An independent data monitoring committee indicated the trials were unlikely to meet their primary endpoint upon completion. Shares of the large-cap slumped to close the week down 34% to $216.71.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced Thursday that its Phase 2b ENCORE-NF clinical trial in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis, did not meet the primary endpoint. Shares closed Friday down 56% to $1.28.

Sage Therapeutics (NASDAQ: SAGE) announced the FDA has approved Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD).

Urovant Sciences (Nasdaq: UROV) announced that its Phase 3 trial evaluating the efficacy and safety of vibegron in adults with symptoms of overactive bladder, met the co-primary endpoints achieving statistical significance over placebo on both reduction in daily urge urinary incontinence (UUI) episodes (p<0.0001) and reduction in daily micturitions (p<0.001). Shares, however, closed the week down 20% to $11.27. For some perspective though, prior to the release, shares had already gained over 220% since its pre-Christmas low, in anticipation of the data.

Lexicon Pharmaceuticals, Inc. (LXRX) and Sanofi (SNY) announced the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application for Zynquista (sotagliflozin) for the treatment of adults with type 1 diabetes in combination with insulin. Shares of Lexicon closed Friday down 22% to $6.20.

Recro Pharma, Inc. (Nasdaq:REPH) also announced that it received its second Complete Response Letter (CRL) from the FDA for their New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam for the management of moderate to severe pain.

Biotech catalysts slated for the final week of March - ALDX* CANF FCSC GLPG PTI PRQR PRTO SGEN

*early 2019

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102) - INVIGORATE
Allergic conjunctivitis

Phase 3 Phase 3 trial to be initiated 1H 2020.
$132.2 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Cancer - advanced liver cancer second line

Phase 2 Phase 2 data did not meet primary endpoint - March 27, 2019. Phase 3 trial to be initiated 2H 2020.
$14.7 million

FCSC – Fibrocell Science Inc.
Recessive dystrophic epidermolysis bullosa

Phase 3 Phase 3 data due 4Q 2020.
$29.2 million

GLPG – Galapagos NV
Rheumatoid arthritis (RA)

NDA Filing NDA filing due 4Q 2019.
$13.8 billion

PRQR – ProQR Therapeutics N.V.
Epidermolysis bullosa

Phase 1/2 Phase 1/2 interim analysis announced March 26, 2019. Future development to be conducted by Wings Therapeutics.
$323.4 million

PRTO – Proteon Therapeutics Inc.
Vonapanitase (PRT-201) PATENCY-2
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 data released Match 28, 2019 did not meet primary endpoint.
$6.6 million

PTI – Proteostasis Therapeutics Inc.
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis

Phase 2 Phase 2 data due 4Q 2019.
$181.5 million

SGEN – Seattle Genetics Inc.
Enfortumab vedotin
Urothelial cancer

PDUFA priority review PDUFA date under priority review is March 15, 2020.
$20.1 billion