BPC July 30 update

Biotech earnings preview for the week ahead; Biotech week in review

Weekly watchlist

The focus for the upcoming week continues to be on companies reporting second quarter earnings, with a number of high-revenue earning companies set to report.

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

REGULATORY:

Iterum Therapeutics plc (Nasdaq: ITRM) announced that the FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for sulopenem. The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial. Shares closed the week down 31% to $0.78.

Ardelyx, Inc. (NASDAQ:ARDX) also announced it received a CRL regarding its NDA for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. The FDA had already identified deficiencies with the NDA filing so with the CRL already expected little impact on price was seen.

CLINICAL UPDATES:

Atreca, Inc. (NASDAQ:BCEL) shares closed the week down 22% to $5.49 following its announcement of initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types. Eight of the 20 participants (40%) experienced stable disease, which was their best response.

Annovis Bio, Inc. (NASDAQ:ANVS) released updated data from its trial of Posiphen in patients with Alzheimer's and Parkinson’s disease. The data showed that patients on the placebo saw improved cognitive impairment compared with Posiphen. Shares dropped to close the week down 71% to $34.43. Other stocks that presented data at the Alzheimer's Association International Conference also sold off on their presentations, with Cassava Sciences, Inc. (NASDAQ:SAVA) the main decliner, falling 44% to $69.53.

Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) shares saw a tumultuous week, initially falling 32% Tuesday following the release of updated oncology data, only to rally 61% the following day with Wells Fargo upgrading its rating of the company from equal-weight to overweight, and a new price target of $14.00. Shares ended the week 8% lower at $2.12.

EARNINGS:

Repligen Corporation (NASDAQ:RGEN) was the big earnings winner of the week, when it reported revenue of $163 million for the quarter, representing year-over-year growth of 86% and organic growth of 69%. In addition, revenue guidance was raised to $625-$645 million for the full year 2021 and adjusted (non-GAAP) fully diluted EPS is expected to be in the range of $2.71-$2.78, an increase from their previous guidance of $2.21-$2.28. Shares closed the week up 17% to $245.70.

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Selection (15) of top revenue earning companies scheduled to report earnings week of August 2-6, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Tue: AMGN BHC INCY JAZZ LLY NBIX

Wed: HZNP IONS SRPT UTHR

Thur: AMRN CHRS ENDP EXEL REGN

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August FDA (PDUFA) decision dates:

Drug Price Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
Dextromethorphan-bupropion (AXS-05)
Major Depressive Disorder

$29.72
+1.19  +4%
PDUFA priority review PDUFA date under priority review August 22, 2021. Noted August 9, 2021 that the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments. Updated August 22, 2021 that the FDA informed the company that its decision has been delayed. No further details provided.
$1.1 billion

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) injection
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus

$15.25
+0.32  +2%
Approved FDA approval announced August 23, 2021.
$763.9 million

ETON – Eton Pharmaceuticals Inc.
Topiramate Oral Solution
Seizures/migraine

$5.13
+0.06  +1%
PDUFA PDUFA date November 6, 2021 (delayed three months).
$126.2 million

JAZZ – Jazz Pharmaceuticals plc
XYWAV
Idiopathic Hypersomnia

$133.22
+1.48  +1%
Approved FDA approval announced August 12, 2021.
$8.2 billion

MRK – Merck & Company Inc.
KEYTRUDA (pembrolizumab)and LENVIMA (lenvatinib)
Renal Cell Carcinoma

$71.68
-0.29  -0%
Approved FDA approval announced August 11, 2021.
$181.4 billion

PFE – Pfizer Inc.
TicoVac
Tick-borne encephalitis (TBE) vaccine

$43.89
-0.58  -1%
Approved FDA Approval announced August 13, 2021.
$246.1 billion

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

$0.91
-0.02  -2%
CRL CRL announced August 13, 2021.
$178 million

SNY – Sanofi
Nexviazyme (avalglucosidase alfa)
Pompe disease

$48.38
+0.19  +0%
Approved FDA approval announced August 6, 2021.
$121.5 billion